Hybrid Regulatory Manager

at Contineum Therapeutics

• Job title: Regulatory Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $138,000 - $148,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Vault
• Location requirements: Hybrid, San Diego, United States

About the role

• Regulatory Manager overseeing the preparation and submission of documents to global health authorities. Ensuring timely regulatory submissions in a collaborative biotech environment.

Responsibilities

• Manage submission timelines and coordinate document deadlines across Regulatory, Clinical, CMC, Nonclinical, and Quality functions
• Prepare, review, format, and publish high quality regulatory documents (e.g., IND/CTA, amendments, DSURs, meeting packages, eCTD modules) for FDA and other global regulatory agencies
• Manage project communication and stakeholder expectations, providing transparent status updates and risk identification
• Experience or familiarity with eCTD publishing systems and document management platforms (e.g., Veeva Vault, Egnyte, SharePoint)
• Conduct technical quality checks, bookmarking, hyperlinking, and ensuring compliance with eCTD and regional requirements
• Maintain submission archives and lifecycle management in accordance with regulatory guidance and internal SOPs
• Track agency correspondence and commitments; assist in preparing responses to health authority requests
• Support development and continuous improvement of regulatory processes, templates, and standards
• Assist with regulatory intelligence monitoring
• Support regulatory authority interactions
• Contribute to inspection readiness and support regulatory audits, as needed

Requirements

• Bachelor's or higher degree in a scientific discipline
• Minimum of 5 years of experience in regulatory operations, regulatory affairs, or eCTD publishing within the biotech/pharmaceutical industry
• Strong attention to detail, organizational skills, and ability to manage multiple tasks under tight timelines
• Excellent written and verbal communication and interpersonal skills
• Experience in a small or early-stage biotech environment
• Strong knowledge of global investigational submission standards and processes (eCTD, FDA/EMA requirements, ICH guidelines)
• Familiarity with regulatory publishing tools (e.g., Lorenz DocuBridge, Veeva RIM, GlobalSubmit, eCTDmanager) and document management systems
• Team player, with the ability to develop collaborative relationships in an often remote online team environment

Benefits

• 90% employer-covered benefits
• Flexible PTO
• A very generous holiday schedule that includes a week off in August and time off around the winter holidays
• A well-stocked kitchen with snacks and beverages
• Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match.
• The comprehensive wellness program includes medical, dental, vision, and LTD coverage.